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www.etq.com | 1.800.354.4476
CONFIDENTIAL: This document contains information that is confidential and proprietary to EtQ, Inc. Disclosure, copying, distribution or use without the express permission of EtQ is prohibited. Copyright 2015 EtQ, Inc. All rights reserved.
ISO 27001 Certified
State of Pharmaceutical Quality, Compliance and
Risk ManagementFull Survey Data
3/31/2015
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The Survey
•Survey conducted in partnership with Pharmaceutical Manufacturing
•Survey objective was to better understand approaches for quality, compliance and risk management being used by pharmaceutical and biopharmaceutical companies and the use of information technology within these efforts
•131 surveys completed
•Manufacturing, quality assurance, quality control, compliance and regulatory professionals from leading pharmaceutical and biopharmaceutical companies comprised the respondent base
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Please classify your organization: (Please choose all that apply)
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Which Quality/Compliance processes do you consider to be your organization’s biggest pain points? (Please choose all that apply)
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How does your organization manage its QMS?
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Do you feel the Quality/Compliance Management system in use by your organization is effective in managing your quality and compliance needs?
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What have been the greatest benefits of your Quality/Compliance Management system? (Please choose all that apply)
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Why has your Quality/Compliance Management system not been effective in managing your quality and compliance needs? (Please choose all that apply)
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Do you feel that your organization has a robust CAPA process?
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What do you believe is the weakness of your CAPA process? (Please choose all that apply)
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How do you manage your CAPA process?
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Do you feel your company would be prepared to handle product recalls or withdrawals in an efficient and timely manner?
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Do you have recall or withdrawal plans in place?
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Do you feel you have a good traceability system to document the recall or withdrawals?
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Have you been involved in a product recall or withdrawal?
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How many product recall or withdrawals have you been involved in?
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Do you feel your organization is ready for an unannounced inspection or audit?
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How do you manage your audit/inspection processes?
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Do you have a comprehensive supplier audit program?
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Do you have a comprehensive supplier management program?
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What are the gaps within your supplier management program? (Please choose all that apply)
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How do you manage your supplier management processes?
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Is your organization using Risk to guide your actions?
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Are you using Risk to guide: (Please choose all that apply)
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What tools are you using to assess your risk? (Please choose all that apply)
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Do you feel your organization goes beyond assessing Risks and is actively managing Risks?
